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NCT Number: NCT02760784

Medium Term Outcome of Nonoperative Treatment After Achilles Tendon Rupture.

A total of 56 patients completed a previous study regarding non-operative treatment for acute achilles tendon rupture. This study consists of an additional follow up after 4-5 years depending on original date of injury.

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Key information

Conditions

Achilles Tendon Rupture

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre Hospital

Hvidovre, Outside US/Canada/Australia, 2650, Denmark

About this study

30 patients suffering from acute Achilles tendon rupture was originally randomized to each arm, and followed up after 6 and 12 months. Of these a total of 56 patients was included in the final analysis, and invited to participate in this additional follow-up, 4-5 years after their original injury. Originally patients was monitored using: ATRS questionnaires, ATRA: Achilles Tendon Resting Angle, Heel Raise Work: number of lifts, lift height and total work, and tests of strength and stiffness in the ankle using a kinetic dynamometer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suffered acute Achilles tendon rupture from April 2011 to March 2012, and then referred to Copenhagen University Hospital Hvidovre.
  • Participated and completed the original study.
  • The patient must be able to speak and understand Danish, as well as be capable to give informed consent to participating.

Exclusion criteria

  • Terminal disease or serious illnesses with an ASA score of 3 or above.
  • Any injury significantly influencing gate and function of the lower extremities other than re-rupture of the Achilles tendon.

Treatment and study plan

Early weight bearing

Behavioral

The intervention implies that the selected patients, will be allowed to bear weight on the injured leg form day 1 while wearing the orthosis, in contrast to the control group, who must wait 6 weaks.

Primary outcomes

  1. ATRS: Achilles Tendon Rupture Score

    Time frame: approximate 5 years

    From initial test 6 and 12 months after injury, and now 4-5 years after.

Secondary outcomes

  1. Heel Raise Work

    Time frame: Test is performed once, 4-5 years after the initial injury

    The total work (joules), max height of lift (mm) and number of lifts is recorded. THe patient is placed standing on one leg on a platform tilted 10 degrees (heel below toes), and is asked to lift the heel (and thereby bodyweight) as high as possible, once every 2 seconds. When the patient can no longer maintain height or pace, the test is finished.

  2. return to sport and return to work

    Time frame: 4-5 years after the initial injury

    When did the patients return to work full or part time, and when did they take up sports again.

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Registry information

Official study title

Medium Term Outcome of Nonoperative Dynamic Treatment of Acute Achilles Tendon Rupture: the Influence of Early Weight-bearing on Clinical Outcome: a Blinded, Randomized Controlled Trial.

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 4, 2016
Registry last updated
Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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